dutasteride

Generic: dutasteride

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dutasteride
Generic Name dutasteride
Labeler aurobindo pharma limited
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

dutasteride .5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-021
Product ID 59651-021_cfb5a2a0-be39-4ef5-b115-47ba5a4b7dd3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202660
Listing Expiration 2026-12-31
Marketing Start 2023-01-20

Pharmacologic Class

Established (EPC)
5-alpha reductase inhibitor [epc]
Mechanism of Action
5-alpha reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651021
Hyphenated Format 59651-021

Supplemental Identifiers

RxCUI
351172
UPC
0359651021309
UNII
O0J6XJN02I
NUI
N0000175836 N0000000126

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dutasteride (source: ndc)
Generic Name dutasteride (source: ndc)
Application Number ANDA202660 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-021-30)
  • 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-021-90)
source: ndc

Packages (2)

59651-021-30 30 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-021-30) 59651-021-90 90 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-021-90)

Ingredients (1)

dutasteride (.5 mg/1)

Linked Drug Pages (1)

Dutasteride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cfb5a2a0-be39-4ef5-b115-47ba5a4b7dd3", "openfda": {"nui": ["N0000175836", "N0000000126"], "upc": ["0359651021309"], "unii": ["O0J6XJN02I"], "rxcui": ["351172"], "spl_set_id": ["b32611f3-50ec-45bb-a671-ea10cec7829d"], "pharm_class_epc": ["5-alpha Reductase Inhibitor [EPC]"], "pharm_class_moa": ["5-alpha Reductase Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-021-30)", "package_ndc": "59651-021-30", "marketing_start_date": "20230120"}, {"sample": false, "description": "90 CAPSULE, LIQUID FILLED in 1 BOTTLE (59651-021-90)", "package_ndc": "59651-021-90", "marketing_start_date": "20230120"}], "brand_name": "Dutasteride", "product_id": "59651-021_cfb5a2a0-be39-4ef5-b115-47ba5a4b7dd3", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["5-alpha Reductase Inhibitor [EPC]", "5-alpha Reductase Inhibitors [MoA]"], "product_ndc": "59651-021", "generic_name": "Dutasteride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dutasteride", "active_ingredients": [{"name": "DUTASTERIDE", "strength": ".5 mg/1"}], "application_number": "ANDA202660", "marketing_category": "ANDA", "marketing_start_date": "20230120", "listing_expiration_date": "20261231"}